Medical Device Packaging & Cleanroom-Compatible Converting
Converted packaging and protective components for medical device and clean-build programs: cleanroom-compatible die-cut parts, foam and film inserts in medical grades, and protective transport supports, plus sterile-barrier Tyvek® pouching through H-O's partner network. H-O converts the materials in Winsted, Connecticut; sterile pouching and cleanroom processing are sourced from qualified partners. ISO 10993 and USP Class VI are cited as material-grade references, not as H-O certifications.
Built for: device makers needing die-cut tray and kit cushioning in qualifying medical grades, clean-build programs that want low-particulate handling, and teams pairing converted inserts with partner-network sterile pouching.
Cleanroom & medical packaging support at H-O Products is in-house converting of low-particulate packaging and protective components for medical device and clean-build programs: die-cut tray and kit cushioning, dunnage, and protective transport supports in medical grades such as PORON® Medical microcellular urethane, BISCO® MS silicone foam (MS80®, MS96®), SSP-2390 silicone, and crosslinked polyethylene foam. The remaining zones and duties are mapped in the When-to-spec list on this page. Values are per the TDS on file.
- Shock & vibration cushioning for a clean device: closed-cell BISCO® MS silicone or crosslinked PE, density matched to device mass
- Tray & kit cushioning in qualifying medical grades: PORON® Medical or SSP-2390 silicone, to the kit drawing
- Locating & corner supports: die-cut supports that hold the device fixed in the carton or tray
- Dunnage & void fill: low-shedding converted materials so the protective layer stays low-particulate
- Peel-and-place packout: pressure-sensitive adhesive applied in-line with kiss-cut liners, single-piece or split-back
- Sterile-barrier pouching: Tyvek® pouching and cleanroom processing through the qualified partner network
Converted packaging for medical and clean-build programs
Cleanroom and medical packaging support covers the converted components that protect, position, and present a device or clean-build assembly: die-cut tray and kit cushioning, low-particulate inserts, dunnage, and protective transport supports, in materials chosen for their handling and biocompatibility references. H-O converts these in Winsted, CT, and coordinates sterile-barrier pouching through qualified partners.
The honest scope matters here. H-O is a die-cutter and converter: we cut, slit, laminate, and apply adhesive to foams, silicones, and films in medical grades on your drawing, the same converted components covered in the medical and clean components application overview. We do not operate an in-house cleanroom, and we do not hold a cleanroom or ISO 13485 certification.
Where a program needs sterile-barrier Tyvek® pouching, cleanroom packaging operations, or a controlled-environment seal, that work is performed by partners qualified for it, and H-O coordinates the converted-component side of the build.
Die cutting, slitting, lamination, and adhesive application of materials in medical grades are performed in Winsted, CT. Sterile-barrier Tyvek® pouching and cleanroom processing are sourced from our partner network. ISO 10993 and USP Class VI are material-grade references taken from the source manufacturer's data; they describe the material, not an H-O certification. For first-article and validation needs, see quality, inspection & validation.
Sterile-barrier pouching through the partner network
Sterile-barrier Tyvek® pouches and lidding are made and sealed by partners qualified for that work. H-O coordinates the converted components that go inside, and routes the pouching to a partner. This is explicitly a partner-network capability, not an in-house cleanroom or sterile-pouching claim.
- Who does what
- H-O converts the foam, film, and adhesive components on your drawing. A qualified partner produces and seals the sterile-barrier Tyvek® pouch or tray lidding. H-O does not run sterile pouching in-house and does not hold a sterile-barrier or cleanroom certification.
- Tyvek® as a barrier material
- Tyvek® (a DuPont™ flash-spun high-density polyethylene) is the common porous sterile-barrier material because it allows gas sterilization while resisting microbial ingress after sealing. The pouch design and seal validation belong to the pouching partner and the device maker.
- How a combined build runs
- For programs that need both, we coordinate the converted inserts and the partner pouching so the parts arrive ready to assemble. Lead times for the partner-network pouching are quoted with the partner and depend on the sterilization and validation path.
- Sterilization paths
- Common device-sterilization methods include ethylene oxide (EO), gamma, and electron beam. The method affects material selection: not every foam or film tolerates every method, which is part of the material review we run before committing a construction. Porous components such as the vents and membranes covered in the filtration and venting application overview get the same method-compatibility review.
H-O converts materials in medical grades and partners for sterile-barrier pouching. We do not represent H-O as ISO 13485 certified, as a sterile-barrier system manufacturer (those responsibilities sit with the device maker and any ISO 13485-certified partner in the chain), or as a cleanroom operator. Sterile-barrier and packaging-validation responsibilities (ISO 11607) sit with the pouching partner and the device maker.
| If your requirement is | Material family to start from | What H-O converts | Reference to confirm on the TDS |
|---|---|---|---|
| Cushioning a device in a sterile tray | BISCO® MS silicone (MS80®, MS96®) | Die-cut cavity inserts and pads, clean edges | ISO 10993 / USP Class VI (vendor-stated) |
| Fine-cell locating pads, tight tolerance | PORON® Medical microcellular urethane | Die-cut pads to ±0.005″ with machined dies | ISO 10993 (vendor-stated) |
| Low-particulate shock and transport protection | Crosslinked polyethylene foam | Corner supports, dunnage, transport cushioning | Closed-cell, low-shed (TDS) |
| Liners, barrier layers, thin laminations | Clean polyester / polyethylene film | Single-layer or laminated film, matched-metal cut | Film grade and thickness (TDS) |
| Sterile-barrier pouch around the parts | Tyvek® (porous sterile barrier) | Converted inserts inside; pouching via partner | Pouch and seal validation (partner) |
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1Send drawing & requirementShare a DXF, DWG, PDF, or STEP with the material callout, thickness, cleanliness and biocompatibility references, and the sterilization path. A device or sample part works too.
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2Material & partner reviewEngineering confirms the material grade and its references, selects the die type, and identifies whether partner-network Tyvek® pouching or cleanroom processing is needed.
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3PrototypeSamples typically 3-5 business days for common configurations once the die is built. Standard production 2 weeks; special orders run custom lead times. Partner pouching is quoted with the partner.
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4ProductionDie-cut, laminated, and finished to drawing, with first-article inspection and lot-code traceability carried through the run, and partner pouching coordinated where required.
Send the part and get a material review
If your drawing has the material, cleanliness references, and the sterilization path, send it over. Engineering confirms the material grade, selects the die type, and identifies any partner-network pouching.
Cleanroom & medical packaging questions
Common questions from engineers speccing medical and clean-build packaging.
Does H-O Products operate a cleanroom?
No. H-O does not operate an in-house cleanroom and does not hold a cleanroom certification. We and convert cleanroom-compatible parts from low-particulate materials in medical grades. Where a build needs a controlled environment or sterile-barrier pouching, that work runs through our partner network or at your facility.
Is H-O certified to ISO 13485?
No. H-O is an ISO 9001:2015 certified organization; we are not ISO 13485 certified. We convert medical-grade materials under our ISO 9001:2015 certified quality management system and coordinate partner-network sterile pouching. Device-level quality-system requirements such as ISO 13485 sit with the device maker and the pouching partner.
What does cleanroom-compatible packaging mean here?
It means converted parts built from low-particulate materials with clean cut edges, suitable for introduction into a controlled environment by the party that operates it. It is not a claim that the parts are cut inside a certified cleanroom. The cleanroom operation, if one is required, runs at a partner or at your facility.
How does Tyvek® pouching work through H-O?
Sterile-barrier Tyvek® pouches and lidding are made and sealed by partners qualified for that work. H-O converts the foam, film, and adhesive components that go inside and routes the pouching to the partner. We do not run sterile pouching in-house and do not hold a sterile-barrier certification; pouch design and seal validation belong to the partner and the device maker.
What materials in medical grades can H-O convert?
From a 687+ material inventory: BISCO® MS silicone foam (MS80®, MS96®), SSP-2390 silicone, PORON® Medical urethane, crosslinked polyethylene, and clean polyester and polyethylene films. Where a grade qualifies, the source manufacturer references it to ISO 10993 or USP Class VI, which we cite from the vendor TDS rather than as an H-O certification.
Related capabilities
Cleanroom and medical packaging sits next to the assembly and quality work that completes a device kit. These pages cover the adjacent capabilities that often share the same program.
Capability overview
All Capabilities
The full set of H-O capabilities.
See all capabilities
Related capability
Assembly, Kitting & Finishing
Multi-component assembly and kitting that brings converted inserts.
Read the page
Related capability
Quality, Inspection & Validation
First-article and in-process inspection that confirms the critical-to-quality dimensions on a converted part.
Read the page
Talk to an engineer
Contact H-O Products
Family-owned since 1971.
Contact us
Last updated · Reviewed by H-O Products engineering (ISO 9001:2015 certified converter, Winsted, CT).
Standards, test methods & technical references
The standards, test methods, and vendor technical data sheets cited on this page. Verify current editions against the publishing body before final spec.
ISO 10993 (multi-part)
Biological evaluation of medical devices: the framework material manufacturers use to assess biocompatibility (cytotoxicity, sensitization, irritation, and related endpoints). Cited as a material-grade reference from the source manufacturer TDS, not as an H-O certification. International Organization for Standardization. iso.org/standard/68936
USP Class VI (USP <88>)
United States Pharmacopeia biological reactivity tests, in vivo, for plastics; Class VI is the most stringent classification. A material-grade reference stated by the source manufacturer, confirmed from the current vendor TDS before quoting a construction. usp.org
ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for development, validation, and routine control. Referenced for EO method-compatibility of converted materials. iso.org/standard/56137
ISO 11137 (series)
Sterilization of health-care products — Radiation. Governs gamma and electron-beam dose setting and validation; referenced for radiation method-compatibility of converted polymers. iso.org/standard/33952
ISO 11607 (Parts 1 & 2)
Packaging for terminally sterilized medical devices. Governs sterile-barrier system and packaging-process validation; this responsibility sits with the pouching partner and device maker, not H-O. iso.org/standard/70799
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes. Held by device makers and qualified pouching partners; H-O operates an ISO 9001:2015 system and is not ISO 13485 certified. iso.org/standard/59752
ISO 9001:2015
Quality management systems — Requirements. H-O Products maintains a certified ISO 9001:2015 quality management system under which material callout, grade, thickness, and lot are recorded per part. iso.org/standard/62085
ASTM D3574
Standard test methods for flexible cellular materials (slab, bonded, and molded urethane foams), including compression-set methods relevant to cushioning grade selection. astm.org/d3574
Rogers Corporation BISCO® silicone product family
Technical data sheets for BISCO® MS medical silicone foams (MS80®, MS96®) and related grades, including the manufacturer biocompatibility references. rogerscorp.com/elastomeric-material-solutions/bisco-silicones
Rogers Corporation PORON® Medical urethane
Technical data sheets for PORON® Medical microcellular urethane: fine cell structure, controlled compression set, and the manufacturer biocompatibility references for the medical grades. rogerscorp.com/elastomeric-material-solutions/poron-industrial-polyurethanes
DuPont™ Tyvek® sterile-barrier media
Flash-spun high-density polyethylene used as a porous sterile-barrier material for medical pouching; pouch design and seal validation belong to the pouching partner and device maker. dupont.com/brands/tyvek
For an accurate quote, include the following with your drawing or sample:
- DXF
- DWG
- STEP
- Material callout
- Thickness
- Cleanliness
- Biocompatibility references
- Sterilization path. A device or sample part works too
Request a cleanroom & medical packaging quote
Send a drawing, a device or sample part, or a description of the package. Engineering confirms the material grade, selects the die type, and identifies any partner-network Tyvek® pouching.
Material data & standards. Material properties, grade designations, and biocompatibility references (ISO 10993, USP Class VI) on this page are taken from the source manufacturers' technical data sheets. H-O Products converts and these materials; the biocompatibility evaluation belongs to the material manufacturer, and H-O cites it as a reference rather than re-certifying it. ISO 10993 and USP Class VI describe the material, not an H-O certification.
Verify against the current vendor TDS for your specific construction and device. Lot-specific documentation is available on request.
Capability scope. Die cutting, slitting, lamination, and adhesive application of materials in medical grades are performed in-house in Winsted, CT. Sterile-barrier Tyvek® pouching and cleanroom processing are sourced from our partner network; H-O does not operate an in-house cleanroom and is not ISO 13485 certified. Sterile-barrier and packaging-validation responsibilities sit with the pouching partner and the device maker. Lead times and minimums vary by material, die type, and construction; expedited handling can be arranged.
| Capability | What it covers |
|---|---|
| All Capabilities | The full set of H-O capabilities: engineering, converting and fabrication, quality, and the finishing and packaging services that complete a part. |
| Assembly, Kitting & Finishing | Multi-component assembly and kitting that brings converted inserts, hardware, and instructions together into a packout-ready device kit. |
| Quality, Inspection & Validation | First-article and in-process inspection that confirms the critical-to-quality dimensions on a converted part, with lot traceability for medical work. |
| Contact H-O Products | Family-owned since 1971, an ISO 9001:2015 certified organization converting materials in medical grades in Winsted, Connecticut, with lot documentation available on request. |